The following data is part of a premarket notification filed by O.r. Solutions, Inc. with the FDA for Warmer 2000ld.
| Device ID | K021289 |
| 510k Number | K021289 |
| Device Name: | WARMER 2000LD |
| Classification | Warmer, Irrigation Solution |
| Applicant | O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR. SUITE W Chantilly, VA 20151 -1689 |
| Contact | Steve Hannes |
| Correspondent | Steve Hannes O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR. SUITE W Chantilly, VA 20151 -1689 |
| Product Code | LHC |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-23 |
| Decision Date | 2002-06-26 |